NCT01755754

A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring

A Multicenter, Open-label, Randomized, Two-period, Crossover Non-inferiority Trial to Assess the Functionality of Female Condoms With a Silicone Elastomer Vaginal Ring

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess the functionality of female condoms with a silicone elastomer vaginal ring.

Detailed description

This was an open-label, randomized, 2-period, crossover non-inferiority trial, conducted over 4.5 months at two research centers in the USA among 81 healthy, monogamous, heterosexual, sexually active couples to assess the functionality of female lubricated, nitrile condoms during vaginal intercourse in the presence and absence of a silicone elastomer placebo vaginal ring.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Silicone Elastomer Vaginal Ring	Silicone Elastomer Vaginal Ring
DEVICE	Female Condom	Female condom

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-12-24
• Last updated: 2017-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study